Clinical headlines in the news

A systematic review has found that lipid-lowering therapies for women who do not have cardiovascular disease do not affect a woman's risk of dying from heart disease.

The review, published in the May 12 Journal of the American Medical Association (JAMA), analyzed 13 studies done between 1996 and 2003. The studies assessed the impact of statin treatment for hyperlipidemia in both women who had cardiovascular disease and those who did not.

Among women without disease, researchers found that drug treatment did not affect either their total mortality or coronary heart disease mortality. Statins may reduce a woman's risk of having a coronary event, although researchers claimed the evidence was not sufficient to reach a definite conclusion.

Among women with cardiovascular disease, lowering lipids reduced their risk of coronary heart disease events and mortality. It did not, however, reduce their total mortality risk.

Authors said they undertook the review because many statin trials do not report results for women alone. Because women have a lower risk of cardiovascular disease than men, researchers said that the number of women you would need to treat for primary prevention of one coronary heart disease event was one in 140—almost twice that for men.

In related news, many of the nation's drug makers are lobbying to make statins available without a prescription.

The renewed effort comes in the wake of the decision made in Britain last week to sell statins over the counter, allowing pharmacists to assess patients' risk of heart disease. Some American drug companies have asked the FDA to follow suit, according to a May 14 Associated Press story.

Drug companies claim that allowing over-the-counter statin sales would result in treatment for many of the estimated 18 million people who are at moderate risk for heart disease. However, medical groups are concerned that at-risk patients will take the drugs without consulting their physician or confronting other risk factors, such as diabetes, smoking and diet.

The following articles appear in today's Annals of Internal Medicine. The full text of the issue is available to College members and subscribers online.

Two studies find positives in low-carb-diets. Two randomized trials compared low-carbohydrate diets with low-fat diets and found that people with low-carb diets had improved triglyceride levels and slightly improved HDL, or so-called "good" cholesterol levels. Changes in LDL, or "bad," cholesterol levels were not significant. The author of one editorial noted that, "We can no longer dismiss very-low carbohydrate diets."

Task force does not recommend for or against screening for suicide risk. The U.S. Preventive Services Task Force examined published research on screening for suicide risk. The accuracy of screening methods for patients at high risk is unknown. Further, few studies show that screening for suicide risk reduces suicide attempts or deaths. No research directly addresses the potential harms of screening for suicide. The Task Force concluded that the evidence isn't strong enough to recommend screening of patients for suicide risk.

Two studies suggest a link between high concentrations of the amino acid homocysteine and increased risk of fractures in older patients.

One study from the Netherlands involving more than 2,400 patients age 55 and older found that those with homocysteine readings in the highest quartile were twice as likely to develop fractures as subjects with lower levels.

A second study, done in the United States, found that men with homocysteine levels in the top quartile were four times more likely to develop hip fractures as men with lower levels, while women in the top 25% doubled their risk of fracture. The U.S. researchers used data on patients enrolled in the Framingham Study who were monitored over 15 years for hip fractures. Both studies were published in the May 13 New England Journal of Medicine

One of the U.S. study's authors quoted in a May 13 Associated Press article said that taking a multivitamin daily and eating foods rich in B vitamins would bring a person's homocysteine levels to acceptable levels. The vitamins have already proven effective in preventing birth defects and decreasing the risk of heart attacks, strokes and Alzheimer's disease.

Researchers noted that they did not establish a causal link between homocysteine levels and fractures, and that further research is needed to study the role of homocysteine in osteoporosis and related fractures.

According to the CDC, fluoroquinolones should no longer be used as a first-line treatment for gonorrhea in gay and bisexual men.

An analysis of data from clinics in 23 U.S. cities found that the total number of gonorrhea cases resistant to ciprofloxacin, ofloxacin and levofloxacin more than doubled in 2003 to almost 1%.

Cases of fluoroquinolone-resistant Neisseria-gonorrhea had the highest occurrence, increasing from 1.8% in 2002 to 4.9% in 2003. That figure was 12 times higher than among heterosexual men, according to a recent CDC press release.

The CDC recommended several treatment options for gay and bisexual men with gonorrhea, including the injectable antibiotics cetriaxone, 125-mg IM (for anorectal, pharyngeal and urogenital cases) and spectinomycin, 2-g IM (for anorectal and urogenital cases only), as well as cefixime, available only in liquid form.

Access to care

A group of large employers will start offering part-time and other uninsured employees purchase options for health coverage next year. The move is an effort to stem rising health care costs and reduce growing numbers of uninsured Americans.

The employer group—which includes General Electric, IBM, McDonald's and Sears, Roebuck—claims that up to 4 million workers may qualify for coverage under the new plan, according to the May 13 New York Times. Annual premiums would range from a few hundred to several thousand dollars. While employers would pay no direct costs, the companies' benefit administrators would negotiate the best premium prices.

There are concerns, however, that many eligible employees won't enroll because they are already in debt or are relatively healthy and willing to take the risk of being uninsured to save money.

The New York Times noted that big employers—ike Sears, which spends $300 million a year on benefits for fulltime employees and has 100,000 uninsured part-time workers—have a vested interest in reducing the number of uninsured patients. The hope is that private sector efforts, along with government initiatives, will eventually bring down the overall cost of care.

CMS update

Medicare beneficiaries report widespread confusion about the terms and options available with different Medicare drug discount cards.

The cards, which cost $30 a year and take effect June 1, are aimed at giving discounts of up to 25% on prescription drugs to Medicare beneficiaries who lack prescription drug coverage. Low-income enrollees are also eligible for $600 worth of subsidies.

However, each card gives different discounts on different drugs, and beneficiaries can subscribe to only one card. With more than 70 cards to choose from, according to the May 12 New York Times, many seniors are confused about which option is the best for them.

CMS has established a Web site so Medicare patients can compare the benefits on specific drug prices with different cards. However, sources quoted in the New York Times claimed that the CMS database may not have accurate prices and may not include all the cards that are available.

CMS is also providing online resources for physicians to help them inform patients about drug card choices.

The Medicare drug-price comparison Web site is online or patients can get price comparisons over the phone by calling 1-800-MEDICARE (1-800-633-4227).

Racial disparities

Black patients are less trusting than white patients of their subspecialist physicians, according to a new survey on patient trust.

Surveyed patients were first-time patients of subspecialists, including cardiologists, gastroenterologists and rheumatologists. Survey results were published in the May 10 Archives of Internal Medicine.

While overall, 79% of surveyed patients claimed they had "complete trust" in the subspecialists, researchers found different results among different ethnic groups.

Among white patients, 81% expressed complete trust, while only 63% of black patients registered that level of trust, according to a press release from Boston's Brigham and Women's Hospital, where the survey was conducted.

The lead author noted that patient trust in physicians affect patients' compliance with recommended therapies, and said that effective communication was particularly critical with black patients.

Factors that increased patient trust included:

the subspecialist listened to the patient;

the patient received all the information he or she needed, and spent as much time as he or she wanted with the subspecialist; and

ACP news

The College's Nominations Committee is seeking candidates for the office of College Treasurer, with nominations to be submitted no later than June 4.

College Treasurer Cyril Hetsko, FACP, has submitted his resignation, after providing excellent stewardship as Treasurer, according to Eric B. Larson, FACP, Chair of the Board of Regents.

The Nominations Committee will now consider candidates to fill that vacancy. Candidates should have experience with investments, pensions, and insurance and financial management issues, and leadership ability to serve as Chair of the College's Finance Committee.

Nominees must be a Master or Fellow of the College, but need not be a member of the Board of Regents at the time of nomination or election.

Nominations must be submitted by a standard structured nominating proposal that includes:

a brief description of a candidate's activities;

special attributes the candidate would bring to the office;

previous and current service in College-related activities; and

service in organizations other than the College, both medical and nonmedical.

A separate letter of nomination and one letter of support must be submitted for each candidate. Letters can be submitted by mail, fax or e-mail to: Nominations Committee, Attn. Pat Carter, 190 N. Independence Mall West, Philadelphia PA 19106; fax: 215-351-2829; e-mail: pcarter@acponline.org.

Nominations must be received by June 4. E-mail Pat Carter with questions or call 215-351-2815.

"Case Studies in Genes and Disease: A Primer for Clinicians," by Bryan Bergeron, MD, provides physicians an easy-to-understand guide to genetics and how gene research can affect the screening and treatment of disease.

The book is written expressly for clinicians who are not familiar with the subject, but who need to understand the latest clinical research in molecular medicine, assess the practical implications of new gene discoveries reported in the popular press, and, most importantly, provide reliable information and advice on advances to their patients.

The book introduces the most clinically relevant topics in the evolving fields of post-genomic and proteomic medicine. It also provides a conceptual framework that allows practitioners to understand and critically evaluate the continuous stream of new findings.

The 272-page book is $30 for ACP members, $33 for non-members. Go online for more information or to order.

You may also order by phone at 800-523-1546, ext. 2600 or 215-351-2600 (product #330300530).

In a recent letter, ACP sent recommendations to CMS about the agency's proposed new patient indicator data element in the participating physician directory.

The letter—which was dated May 12 and sent to Mark B. McClellan, ACP Member, CMS administrator—recommended that CMS give physicians the option of indicating whether they accept new patients on a limited basis. ACP also recommended that CMS provide a list of options, such as a drop-down box, that would permit physicians to indicate why they may not be accepting new Medicare patients.

The letter also urges CMS to identify the source of any sanction information that would be included in the directory. And the letter asked CMS to expand the directory to include all physicians, who could be designated as participating, non-participating or accepting "private contracts only."

In a statement sent this week to Medicare's Practicing Physicians Advisory Council (PPAC), ACP asked the council to support several changes in CMS' systems of provider enrollment and regulation.

Several recommended changes involved the provider enrollment chain ownership system, which is a centralized system for compiling and updating physician enrollment information. ACP is asking PPAC to recommend the following to the CMS:

Adopt a contingency plan for processing physician enrollment applications or changes. Having a fallback plan would avoid processing delays that could disrupt a practice's cash flow.

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